Generic Aldactone

1. Denomination

Aldactone

2. Active Substance

Spironolactone

3. Indications for Use.

— essential hypertension (within a combined therapy);
— edema syndrome in chronic heart failure (it may be used in the form of monotherapy and in combination with a standard therapy);
— the states in which a secondary hyperaldosteronism may develop (adrenopathy), including the liver cirrhosis accompanied with dropsy and/or edemas, nephrotic syndrome and other state accompanied with edemas;
— hypopotassemia/hypomagnesemia (as an auxiliary remedy for their prophylaxis during diuretic therapy and when it is not possible to use other potassium level correction modes);
— primary hyperaldosteronism (Conn’s syndrome) — for a short pre-surgery course of treatment;
— for making a diagnosis of primary hyperaldostrenism.

4. Action

Spironolactone efficiently reduces the retention of liquid and salts in the body, reduces in quantity of the hormone responsible for the liquid balance produced by adrenal glands in the body.

5. Posology and Administration

The drug should be taken orally. Dosage regimen should be established individually. Common doses for adults: 25-200 mgм/daily in one or several intakesс; if needed, the dose may be increased up to 400 mg/daily. Children are usually administered on the basis of 3 mg/kg/daily, single-shot or in 2 intakes, a dose should be chosen individually.

6. Counterindications

— Addison disease;
— hyperpotassemia;
— hyponatremia;
— kidneys failure of a severe degree (CK less than 10 ml/min);
— anuria;
— pregnancy;
— lactation period;
— hypersensitivity to any of Spironolactone’s component.

7. Should Be Taken with Precautions, if…

Spironolactone should be administered with caution in hypercalcemia, sugar diabetes (when there is a confirmed or supposed chronic kidneys failure), diabetic nephropathy, surgical intervention, local or general anesthesia, disorders in menstrual cycle, increase of lacteal glands, liver failure, liver cirrhosis, also caution is needed in elderly patients.

8. Interface with Other Medications

The use of the drug simultaneously with the medications not prescribed by the attending doctor may result in unpredictable side effects.

9. Overdosing

Symptoms: nausea, vomit, drowsiness, dizziness, consciousness fog, cramp in leg, skin rash, diarrhea; body dehydration and damage of water-electrolytic balance are possible.

10. Side Effects

Dizziness, drowsiness, lethargy, apathy, headache, ataxy, consciousness fog. Nausea, vomit, diarrhea, spasms, intestinal constipation, gastritis, canker and bleeding in the digestive tract, compromised liver function. Pain in lacteal glands, disorders of erection in men, reduction of potency in men, disorders of menstrual cycle or retention of menstrual cycle, uterine bleeding in menopause, having nothing to do with menstruation, overgrowth of hair on male-pattern in women, change of the voice in women. Skin eruption, itching, hives. Cramp in legs, benign neo formations of lacteal gland, pain in breast, blood compositional disorder, medicinal fever.

11. Pregnancy and Lactation

The use of Spironolactone is counterindicated in the I-st trimester of pregnancy. In the II-nd and the III-d trimester of pregnancy Spironolactone therapy is possible only on strict indications, provided a prospected therapy effect exceeds a potential risk for the fetus. During the treatment breastfeeding should be stopped.

12. Driving

Against the background of the side effects which are probable in Spironolactone therapy vehicle driving became impossible, but in case if symptoms of side effects are not developed, it is quite possible to drive a car.

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